Many people who work in the field of aseptic manufacturing may never have heard of aseptic non-touch technique (ANTT). That’s because it was actually pioneered in nursing, where many aseptic techniques “evolved more from anecdotal evidence and ritualistic practice than from empirical research,” according to an article published in the Nursing Times. In an effort [...]
The time, equipment, training, and cost required to create compliant parenteral products make outsourcing to parenteral contract manufacturers an attractive option for pharmaceutical companies. Because parenteral drugs bypass the body’s natural defenses, they must be totally sterile upon delivery, which means they must be sterilized completely during manufacture or processed aseptically from beginning to end. [...]
Right now, pre-filled syringes are one of the most popular forms of delivery for countless parenteral products, both under hospital conditions and at home. What’s more, their popularity has grown exponentially in recent years, and shows no sign of slowing in the coming decades. However, the ubiquity of parenteral products delivered via pre-filled syringes brings [...]
Aseptic processing is used in many industries, for many purposes besides the production of sterile drug product. For example, aseptic processing has become the industry standard for handling liquid food products such as milk, fruit juice, and others—not to mention growing in popularity for foods like cottage cheese, vegetable soups, and baby food, to name [...]
The lyophilization cycle is a key component in the manufacturing process of many pharmaceutical products. Understanding lyophilization requires a basic understanding of sublimation—the process by which a solid transitions directly to a vapor or gaseous state without first passing through a liquid phase. Sublimation is part of the lyophilization cycle, during which ice or other [...]
Clinical trials are an integral part of the drug development process, but successful clinical trials require materials that can be quickly and reliably produced in accordance with the dynamic demands of trial protocols. The manufacture of clinical trial material (CTM) often happens at smaller scale than other contract manufacturing operations, and may come with highly [...]
Monoclonal antibody production is expensive and complex but produces highly specific antibodies which can target antigens extremely effectively. Antibodies attach to antigens at the antigens’ epitopes. The specificity of an antibody’s variable region is what determines its affinity for the epitope. Some antigens may be so chemically similar, however, that antibodies raised against one antigen [...]
In the last few years, monoclonal antibody (MAb) products have become some of the top-selling drugs in the world. In fact, the biologics market as a whole, which already accounts for more than 20 percent of drug sales worldwide, is growing at a rate of anywhere from 10 to 15 percent per year. This includes [...]
Despite surface similarities, biologics process development and manufacturing sciences are two very different disciplines. They require different sets of skills, draw from varied areas of expertise, and have distinct goals. Yet, when they work in tandem, they can accelerate the timeline for bringing a new biologics product to market. Process development sets forth the parameters [...]
Challenges of adapting vaccines for oral administration remain significant, but emerging techniques promise greater flexibility and efficiency. Pressures to streamline development and production continue to ramp up in many areas of the pharmaceutical industry. This is particularly true in the field of solid oral dosage forms for vaccines, which now account for more than 60 [...]
